Kornimate/medical-research-clean huggingface dataset:
evaluation of psychometric testing properties of severity symptom grading scale of influenza infection: flu-pro stage iii

Conditions: Influenza; Influenza-like Illness

Summary: there is no standardized method for evaluating the symptoms of influenza. a standardized instrument for measuring influenza symptoms, with appropriate scientifically derived content and construct validity would have value for public health in terms of use as a validated outcome measure in interventions to treat or prevent influenza. the instrument also could serve as part of an overall measure of severity of illness in influenza. previous efforts in participant reported outcomes (pro) for influenza (i.e. flu-pro stage i and stage ii) focused on the elicitation and evaluation of items for inclusion in the instrument. the overarching objective of this protocol - flu-pro stage iii - is to conduct instrument validation to evaluate item properties and, if need be, reduce the number of items, and quantitatively validate the performance of the final measure.

the overarching purpose of this study is to develop a single, standardized measurement scale of participant influenza symptoms for use in clinical studies involving adult and pediatric participants. the development of an instrument for participant reported outcomes of influenza was composed of three stages, as described below: stage i. elicitation interviews in a group of volunteers with laboratory-confirmed influenza to inform the development of the instrument, including its content and structure (item phrasing, length, response options, recall). stage ii. evaluative interviews with a second set of volunteers with laboratory-confirmed influenza to assess comprehension and interpretability of the instrument and draft item pool from the respondent's perspective. stage iii. item reduction and instrument validation in a third set of volunteers to evaluate item properties and quantitatively validate the performance of the final measure. this protocol will describe the rationale, design, data collection procedures, and analysis methods for stage iii - item reduction and instrument validation.

Eligibility criteria:
inclusion criteria: * deers eligible * adults ≥18 years * influenza or influenza-like symptoms as defined by one or more of the following: * positive influenza test by pcr, culture, and/or rapid antigen testing * fever with temperature ≥100.4° f \[38° c\] and respiratory symptoms\* or * subjective fever and respiratory symptoms\* \[\*respiratory symptoms: cough, or sputum production, or shortness of breath, or chest pain, and/or sore throat\] * speak and read english * access to the internet through computer, laptop, tablet, or smartphone exclusion criteria: * individuals who do not have access to the internet by computer, laptop, tablet, or smartphone * individuals with cognitive and/or physical disabilities who are unable to use a touch screen or computer mouse to enter information into an internet-based survey
influence of expectations on rumination

Conditions: Depression

Summary: the study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.

healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. they will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). then sad mood is induced by mood-suggestive music and negative autobiographic recall. then participants in the experimental group take the "medication". afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "think about what your feelings might mean."). sadness will be assessed before and after the negative recall task and also after the rumination induction. state rumination will be assessed before the recall task and after the rumination induction.

Eligibility criteria:
inclusion criteria: * healthy volunteers * fluent in german language exclusion criteria: * mental disorders * allergic to capsaicin * allergic to sesame oil * intake of psychopharmacological drugs in the last four weeks * intake of illegal drugs in the last two weeks * consumption of alcohol in the last twelve hours * students in medicine, pharmacy, or psychology * completed studies in medicine, pharmacy or psychology * current pregnancy or lactation * cardio vascular disease * kidney disease * liver disease
self-advocacy for independent life (sail) after tbi

Conditions: TBI (Traumatic Brain Injury)

Summary: traumatic brain injury (tbi) has been conceptualized as a chronic health condition, warranting self-advocacy for health management services across the lifespan. successful self-advocacy requires a combination of cognitive and communication skills (problem solving, organization, negotiation, etc), which may be impaired following tbi. this project focuses on developing and testing the efficacy of an intervention to enhance self-advocacy skills in individuals who have sustained tbi. this two-arm, randomized controlled trial will include approximately 74 participants, recruited in 4 waves of approximately 18-20 per wave, with each wave recruited from a different geographic area of the state. the primary hypothesis states that participants receiving the treatment intervention will demonstrate significantly greater improvements in self-advocacy beliefs (sas) from baseline to post-intervention as compared to participants in the control group. treatment will consist of interactive 4-session workshops along with 2 booster phone calls. control participants will receive a copy of a self-advocacy workbook after all assessments are completed. baseline, post-treatment and two follow-up assessments will take place.


Eligibility criteria:
inclusion criteria: * documented tbi due to an external mechanical force * received inpatient or outpatient rehabilitation for tbi * at least 9 months post tbi * able to travel independently in the community * able to attend intervention sessions exclusion criteria: * unable to read or speak english well enouth to complete assessments and actively participate in study intervention * currently in inpatient tbi rehabilitation * previously participated in a sail program * participating in another research trial * unable to perform neuropsychological baseline assessment * score of 30 or above on gses

Keywords: traumatic brain injury advocacy
study of the wearable defibrillator in heart-failure patients

Conditions: Heart Failure; Ventricular Dysfunction; Sudden Death; Sudden Cardiac Arrest; Ventricular Tachycardia; Ventricular Fibrillation

Summary: the purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.


Eligibility criteria:
inclusion criteria: * patients with nyha class iii or iv during the past month and one or more of the following: * hospitalization for cardiac decongestion and stabilization, * advanced heart failure receiving intravenous diuretics/inotropics in an outpatient clinic, or * awaiting cardiac transplantation * patients with left ventricular ejection fraction ≤ 35% and either one of the following: * coronary revascularization within 3 calendar months prior to enrollment, or * heart failure of non-ischemic origin diagnosed within 3 calendar months prior to enrollment. * patients awaiting icd re-implantation following device explantation or lead extraction, * patients hospitalized with acute myocardial infarction and killip class iii/iv. exclusion criteria: * the presence of an implantable cardioverter defibrillator prior to enrollment. * advanced cerebrovascular disease. * non-cardiac terminal illness associated with reduced likelihood of survival for the duration of the study. * use of supplemental oxygen in an outpatient setting requiring an external oxygen tank. * pregnancy.

Keywords: heart failure ventricular dysfunction sudden death sudden cardiac arrest ventricular tachycardia ventricular fibrillation wearable defibrillator
walking in the hibbot: is gait improved?

Conditions: Cerebral Palsy

Summary: the aim of the study is to assess the impact of the innovative walking aid hibbot on the functions, activity and participation of young children with cerebral palsy, in comparison with conventional walking aids.


Eligibility criteria:
inclusion criteria: * at risk of or diagnosed with cerebral palsy, based on mri (ucp 86 - 89 % sensitivity) or hine (ucp 98% ) or standard motor assessment * age 18 months - 6 years * gmfcs level ii - iv =with potential (=able to stand and walk when supported by a therapist at the level of the pelvis and lower trunk) * sufficient cooperation to complete the tests. exclusion criteria: * hip dysplasia * fixed contractures in the lower limb * botox infiltration \< 6 months prior to inclusion * surgery \< 12 months prior to inclusion * insufficient understanding of the interventon and tests (based on mental level assessment) * refractary epilepsia

Keywords: gait biomechanics
thunder trial - local taxan with short time contact for reduction of restenosis in distal arteries

Conditions: Arterial Occlusive Diseases

Summary: the thunder trail is a randomized , double-blinded, placebo controlled german multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.

drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. we could show that a non-stent based delivery of taxan was equal or superior to drug eluting stents in an animal model. this was both true for the coronary arteries and peripheral vessels. in a prospective blinded trail \>135 patients are randomized either to receive taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. one group serves as control. there were no limitations due to lesion length. follow-up angiography will be after 6 months, 12 months and 2 years.

Eligibility criteria:
inclusion criteria: * adults * chronic occlusions and stenosis (history at least 6 weeks) ≥70 % diameter stenosis \> 2cm in the arteria femoralis superficialis or arteria poplitea * various criteria assuring ethical issues and follow up exclusion criteria: * conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication. * pregnancy can not be excluded * doubts in the willingness or capability of the patient to allow 6 months follow up

Keywords: intervention peripheral vascular disease drug restenosis 18 years and above
educational intervention in patients with migraine

Conditions: Migraine

Summary: introduction: despite the numerous pharmacological treatment options available for migraine attacks and for the prevention of thereof, less than 30% of patients with migraine are highly satisfied with their current treatment. in recent decades, there has been a radical change in the way we view pain, thanks to developments in neuroscience. it is currently considered that pain does not originate in the peripheral nociceptors, but rather in a network of brain regions (the pain neuromatrix), the synchronous activation of which is necessary and sufficient to generate the perception of pain. migraine may be the expression of this exaggerated perception of threat, a perception that, from a cultural learning perspective, it may be possible to modify by adjusting beliefs and behaviours that favour the onset of an attack. the aim of this study was to assess the effectiveness of a group educational intervention about concepts of pain neuroscience, in the management of migraine, compared to routine medical interventions, in primary care health centres of alava.

the aim of this study was to assess the effectiveness of a group educational intervention about concepts of pain neuroscience, in the management of migraine, compared to routine medical interventions, in primary care health centres of alava. after recruitment, patients were interviewed by the research team members in charge of the assessments. in these interviews, data were collected on the following: demographic characteristics, beliefs regarding migraine, coping strategies for migraine attacks, the midas questionnaire (16), medication taken, work leave, emergency department attendances and limitation of daily activities due to migraine, during the previous 3 months. subsequently, we carried out further assessments over the telephone after 3, 6 and 12 months. very few studies assessing preventive treatments for migraine have performed assessments 12 months after initiating prophylactic treatment, most having followed-up patients for 6 months at most. we believe, however, it is necessary to continue assessments for at least 1 year to properly test the efficacy of treatment for chronic illnesses like migraine. the individuals carrying out the assessment were blinded to group allocation. the clinical follow-up was the same for both groups, the only difference in their management being the educational intervention itself.

Eligibility criteria:
inclusion criteria: * belong to one of these health centres of primary care: san martín, sansomendi, lakuarriaga, gazalbide and zabalgana, * diagnosed with migraine (icd-9-cm diagnosis code 346) who had at least one migraine attack every month despite treatment. exclusion criteria: * we excluded patients with mental illness, cognitive impairment or language deficits that might hinder completion of follow-up and patients that would not be able to attend to all the sessions of the intervention or had received training as part of the previous pilot study.

Keywords: migraine disorders educational models neuroscience
usefulness of exhaled no in the differential diagnosis acute eosinophilic pneumonia and bacterial pneumonia

Conditions: Acute; Eosinophilic Pneumonia

Summary: acute eosinophilic pneumonia (aep) is diagnosed by cell count analysis of bronchoalveolar lavage fluid. however, the performance of bronchoscopy is not easy for patients with aep, because they usually have hypoxia. exhaled nitric oxide (feno) is usually elevated in the patients with eosinophilic inflammation such as asthma, but there is no previous studies feno in the patients with aep. investigators hypothesized that feno elevated significantly in patients with aep, and feno can be used as non-invasive diagnostic method in patients who are clinically suspected with aep, especially when the performance of bronchoscopy is difficult.


Eligibility criteria:
inclusion criteria: * all patients who visited the study hospital with bilateral pneumonic infiltration. exclusion criteria: * patients who do not agree with our study protocol

Keywords: acute eosinophilic pneumonia exhaled nitric oxide
efficacy and safety of fexofenadine in mild to moderate persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg bid compared to placebo in the treatment of subjects with mild to moderate persistent asthma

the incidence of respiratory allergy in the us has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. histamine is an important chemical mediator of inflammation in asthma. the benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment. recent evidence indicates that in addition to h1-receptor antagonism, some of the newer nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma. the purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg bid compared to placebo in the treatment of subjects with mild to moderate persistent asthma.

Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-breastfeeding females 12 through 80 years of age * fev1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at visit 1 or visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry) * improvement in fev1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry or documented during the previous 12 months at the study site. * use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use). exclusion criteria: * otherwise healthy
low rate fluoroscopy to reduce radiation dose during coronary angiography and intervention

Conditions: Stable Angina; Unstable Angina; Acute Coronary Syndrome

Summary: objectives: to determine the efficacy of low rate fluoroscopy at 7.5 frames per second (fps) vs. conventional 15 fps for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach. background: transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. low rate fluoroscopy has potential to reduce radiation exposure.

methods: patients undergoing transradial approach diagnostic angiography ± ad hoc pci, wil be randomized to fluoroscopy at 7.5 fps vs. 15 fps prior to procedure. both 7.5 and 15 fps fluoroscopy protocols will be configured with a fixed dose per pulse of 40 ngy. primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µsv), patient radiation dose (expressed as dose-area product in μgy.m2), and fluoroscopy time.

Eligibility criteria:
inclusion criteria: * patients undergoing elective, urgent or emergent cardiac catheterization procedures with or without ad hoc pci, via transradial approach are eligible. exclusion criteria: * 1) non-transradial access and 2) participation in research project(s) requiring higher ie 30 fps cine angiography.

Keywords: fluoroscopy radiation transradial diagnostic angiography cardiac coronary angioplasty
effect of planter vibration and otago exercise in old hemiplegic patients

Conditions: Balance Disorders

Summary: this study aims to determine effect of plantar vibration and otago exercise on risk of fall and quality of life in hemiplegic elderly

stroke is one of the major causes of permanent disability. stroke can have many causes and occurs mainly in old age, hemiplegic patients have a two-fold higher risk of falling than other patients of the same age or gender, beside fall in older adults can cause significant physical and psychological injury to the individual. otago exercises are the interventions given for fall prevention in elderly and showed good results with hemiplegic cases as well, it is easy and could be done by old adults even at home. plantar vibration as a cheap, portable, and easy applicable, saving time and with no effort could be a good choice as a treatment tool to be added for old hemiplegic patients treatment programme. thus applying an easy and effective programme for old hemiplegic subjects that reduces their risk of fall and improves their balance and adl and at the same time helps them to conduct it easily and adhere to it should be our target to full fill.

Eligibility criteria:
inclusion criteria: * first-ever stroke * age 65-75years * duration since stroke ≥6 months * balance deficit confirmed by one leg stance (ols) test; patient unable to stand on affected leg for 30s with eyes open * able to walk without the use of aids .able to understand verbal commands. exclusion criteria: * participation in other treatment protocols for balance * presence of conditions other than stroke affecting balance * history of lower-limb surgery within the previous year * fixed ankle contractures * cognitive impairments (mmse\<24)

Keywords: hemiplegic elderly
identification and validation of biomarkers of acute kidney injury recovery

Conditions: Acute Kidney Injury

Summary: this study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (aki).


Eligibility criteria:
inclusion criteria:a. * males and females 21 years of age or older * receiving care in an intensive care unit * expected to remain in the icu for at least 48 hours after enrollment * use of indwelling urinary catheter as standard care at the time of enrollment * subject must have acute kidney injury (kdigo stage 2 or stage 3) at the time of the first sample collection * first sample must be collected within 36 hours of meeting kdigo stage 2 criteria * written informed consent provided by patient or legally authorized representative (lar) exclusion criteria: * prior kidney transplantation * comfort-measures-only status * already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment * history of human immunodeficiency virus (hiv) or hepatitis virus (based upon available medical records) infections (note: hiv or hepatitis testing need not be performed for enrollment in this study.) * special populations, pregnant women, prisoners or institutionalized individuals * patient meets any of the following: * active bleeding with an anticipated need for \> 4 units prbc in a day * hemoglobin \< 7 g/dl * any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes

Keywords: kidney renal
semitendinosus graft as meniscal transplant

Conditions: Patient Satisfaction; Graft Failure; Osteo Arthritis Knee; ACL; Meniscus Tear

Summary: removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. different implants have been suggested to substitute a removed meniscus. meniscal allograft transplantation is not widely available due to costs and availability. the semitendinosus tendon is a known graft with biological properties with potential to remodel and revascularize in an intraarticular environment such as anterior cruciate ligament reconstruction. the objective for this study was to investigate whether the semitendinosus tendon graft could function as a meniscal transplant.


Eligibility criteria:
inclusion criteria: * previous subtotal or total meniscectomy * post meniscectomy symptoms * no osteoarthritic changes on radiography more than ahlbäck 1 * knee aligment (hip-knee-angle) +/- 3° * no persisting acl insufficiency exclusion criteria: * difficulty understanding the instructions * current psychiatric diagnosis * smoking

Keywords: meniscus transplantation